[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35109-35115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15743]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0064; FRL-9962-96]
Fenamidone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fenamidone in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July 28, 2017. Objections and
requests for hearings must be received on or before September 26, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0064, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
[[Page 35110]]
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0064 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 26, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0064, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E8434) by IR-4, Rutgers University, 500 College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.579 be
amended by establishing tolerances for residues of fenamidone (4H-
imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino)-, (S)-) in or on the following raw agricultural
commodities: Basil, fresh leaves at 30 parts per million (ppm); and
basil, dried leaves at 200 ppm. Additionally, tolerances were proposed
for the crops in the proposed crop subgroup 4-15A, leafy greens
subgroup at 60.0 ppm, including amaranth, Chinese; amaranth, leafy;
aster, Indian; blackjack; cat's whiskers; chervil, fresh leaves; cham-
chwi; cham-na-mul; chipilin; chrysanthemum, garland; cilantro, fresh
leaves; corn salad; cosmos; dandelion; dang-gwi; dillweed; dock; dol-
nam-mul; ebolo; endive; escarole; fameflower; feather cockscomb; good
king henry; huauzontle; jute, leaves; lettuce, bitter; lettuce, head;
lettuce, leaf; orach; parsley, fresh leaves; plantain, buckhorn;
primrose, English; purslane, garden; purslane, winter; radicchio;
spinach; spinach, malabar; spinach, New Zealand; spinach, tanier; swiss
chard; and violet, Chinese; the crops in the proposed crop subgroup 4-
15B, Brassica leafy greens subgroup at 55 ppm, including arugula;
broccoli raab; broccoli, Chinese; cabbage, Abyssinian; cabbage,
seakale; Chinese cabbage, bok choy; collards; cress, garden; cress,
upland; hanover salad; kale; maca; mizuna; mustard greens; radish,
leaves; rape greens; rocket, wild; shepherd's purse; turnip greens; and
watercress; the crops in the proposed crop subgroup 22B, leaf petiole
vegetable subgroup at 60 ppm, including cardoon; celery; celery,
Chinese; fuki; rhubarb; udo; and zuiki; the crops in the proposed crop
group 5-15 (Brassica head and stem vegetable) at 5.0 ppm, including
broccoli; brussels sprouts; cabbage; cabbage, Chinese, napa; and
cauliflower; cottonseed subgroup 20C at 0.02 ppm; kohlrabi at 5.0 ppm;
celtuce at 60 ppm; and fennel, Florence, fresh leaves and stalk at 60
ppm. That petition also requested that the following existing
tolerances be removed after the petitioned-for tolerances are issued
since they would be superseded by the new tolerances: Brassica, head
and stem, subgroup 5A at 5.0 ppm; Brassica, leafy greens, subgroup 5B
at 55 ppm; cotton, undelinted seed at 0.02 ppm; cilantro, leaves at 60
ppm; and vegetable, leafy, except Brassica, group 4 at 60 ppm. That
document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of filing.
EPA is establishing tolerances similar to those requested by the
petitioner (the leafy greens crop subgroup 4-15A; the Brassica leafy
greens crop subgroup 4-15B; the leaf petiole vegetable crop subgroup
22B; and the Brassica head and stem vegetable crop group 5-15), except
that due to the recent establishment of the new crop groups, the Agency
is referencing the current crop groups. Additionally, in order to
harmonize with Canada, the Agency is establishing a single tolerance
for leafy vegetable crop group 4-16 rather than two separate tolerances
for each of the crop subgroup 4-16A and 4-16B.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fenamidone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fenamidone follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
[[Page 35111]]
The target organs in fenamidone are the liver in mice, rats and
dogs, and the thyroid in rats. Liver effects include liver weight
increases, liver enlargement, and histopathological observation.
Enlarged thyroid, increased thyroid weights with an increase incidence
of a slight, diffuse follicular hypertrophy and/or hyperplasia were
observed in rats of both sexes in the chronic toxicity study.
In the acute neurotoxicity study in rats, clinical signs included
staining of the anogenital region, mucous in the feces, hunched
posture, and unsteady gait. In the subchronic neurotoxicity study in
rats, marginal decreases in brain weights were observed only in high
dose males. Additionally, decreased brain weight occurred in the rat
reproduction study. In a developmental neurotoxicity study in Wistar
rats, no neurobehavioral effects and no neuropathological changes were
observed at any dose in the offspring, but decreased body weight was
observed during pre- and post-weaning.
Fenamidone did not demonstrate qualitative or quantitative
increased susceptibility in the rat or rabbit developmental toxicity
studies or the 2-generation rat reproduction study. There were no
developmental effects up to the highest dose tested and in the presence
of maternal toxicity in rats and rabbits. In the reproduction study in
rats, decreased absolute brain weight in F2 female pups occurred at the
same dose levels as decreased absolute brain weight in F1 parental
females; there were no effects on fertility or other measured
reproductive parameters. Immunosuppression was demonstrated at the
highest dose tested in the immunotoxicity study; however, the existing
risk assessment points of departure are lower and are protective of
this potential effect.
Fenamidone is classified as ``not likely to be a human carcinogen''
by all relevant routes of exposure. All mutagenicity studies were
negative for both the parent and plant metabolites (RPA 412636, RPA
412708, and RPA 410193), except the parent induced mutant colonies at
the tk locus and increased chromosomal aberrations in human peripheral
blood.
Specific information on the studies received and the nature of the
adverse effects caused by fenamidone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
http:www.regulations.gov in the document titled ``Fenamidone: Human
Health Risk Assessment to Support the Section (3) Registration on Basil
and Crop Group Expansion on Brassica Head and Stem Vegetables; Leafy
greens; Brassica Leafy Greens; and Cottonseed'' on page 33 in docket ID
number EPA-HQ-OPP-2016-0064.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for fenamidone used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fenamidone for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. NOAEL = 125 mg/kg/ Acute RfD = 1.25 mg/ Acute Neurotoxicity in Rats: LOAEL
day. kg/day. = 500 mg/kg/day based on
UFA = 10x........... aPAD = 1.25 mg/kg/ urination, staining/soiling of
UFH = 10x........... day. the anogenital region, mucous in
FQPA SF = 1x........ the feces, and unsteady gait in
the females.
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Chronic dietary.................. NOAEL= 2.83 mg/kg/ Chronic RfD = 2 Year Chronic Toxicity/
(All populations)................ day. 0.0283 mg/kg/day. Carcinogenicity in Rats: LOAEL =
UFA = 10x........... cPAD = 0.0283 mg/kg/ 7.07/9.24 mg/kg/day (M/F) based
UFH = 10x........... day. on increase in severity of
FQPA SF = 1x........ diffuse thyroid C-cell
hyperplasia in both sexes.
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Cancer (Oral, dermal, inhalation) Fenamidone is classified as ``not likely to be a human carcinogen'' by all
relevant routes of exposure.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenamidone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenamidone tolerances in 40 CFR
180.579. EPA assessed dietary
[[Page 35112]]
exposures from fenamidone in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for fenamidone. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/
WWEIA). As to residue levels in food, EPA used field-trial residue
values, assumed 100 percent crop treated (PCT) for all commodities, and
incorporated Dietary Exposure Evaluation Model (DEEM)TM
default processing factors and empirical factors for processed
commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, EPA used field-trial
residue values, assumed 100 PCT for all commodities, and incorporated
Dietary Exposure Evaluation Model (DEEM)TM default
processing factors and empirical factors for processed commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenamidone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue/Percent Crop Treated information. Although
the Agency assumed 100 percent crop treated for all commodities, EPA
used anticipated residue information in the assessment for this
fenamidone tolerance action. Section 408(b)(2)(E) of FFDCA authorizes
EPA to use available data and information on the anticipated residue
levels of pesticide residues in food and the actual levels of pesticide
residues that have been measured in food. If EPA relies on such
information, EPA must require pursuant to FFDCA section 408(f)(1) that
data be provided 5 years after the tolerance is established, modified,
or left in effect, demonstrating that the levels in food are not above
the levels anticipated. For the present action, EPA will issue such
data call-ins as are required by FFDCA section 408(b)(2)(E) and
authorized under FFDCA section 408(f)(1). Data will be required to be
submitted no later than 5 years from the date of issuance of these
tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fenamidone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenamidone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier II Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS)--Index Reservoir model and Pesticide Root
Zone Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of fenamidone for acute exposures are estimated
to be 41.7 parts per billion (ppb) for surface water and 207 ppb for
ground water, and for chronic exposures are estimated to be 11.9 ppb
for surface water and 207 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For both the acute and chronic
dietary risk assessments, the ground water concentration value of 207
ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fenamidone is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found fenamidone to share a common mechanism of
toxicity with any other substances, and fenamidone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fenamidone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Fenamidone did not
demonstrate any qualitative or quantitative increased susceptibility in
the rat and rabbit developmental toxicity studies or the 2-generation
rat reproduction study. In rabbits and rats, there were no
developmental effects up to the highest dose tested and in the presence
of maternal toxicity. In the reproduction study in rats, decreased
absolute brain weight in F2 female pups occurred at the same dose
levels as decreased absolute brain weight in F1 parental females.
In the developmental neurotoxicity (DNT) study in rats, no maternal
toxicity was observed at doses up to 4,700 ppm (429 mg/kg/day),
although offspring systemic toxicity, manifested as decreased body
weight (9-11%) and body weight gain (8-20%) during pre-weaning and
decreased body weight (4-6%) during post-weaning, occurred at the
highest dose tested (429 mg/kg/day). The offspring NOAEL of 1,000 ppm
(92.3 mg/kg/day) indicates an increased susceptibility of offspring.
Nevertheless, the concern for the increased susceptibility observed in
the DNT is low because: (1) Of the lack of neurobehavioral or
neuropathological changes in the offspring at any dose; and (2) the
endpoints used for the various risk assessment scenarios are much more
sensitive than that of the decreased bodyweight of the offspring
occurring at almost half the limit-dose (429 mg/kg/day).
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF
[[Page 35113]]
were reduced to 1X. That decision is based on the following findings:
i. The toxicity database for fenamidone is complete.
ii. There was no evidence of neurotoxicity in the subchronic
neurotoxicity study submitted for fenamidone. There was evidence of
neurotoxicity (urination, staining/soiling of the anogenital region,
mucous in the feces and unsteady gait in females) in the acute
neurotoxicity study, and EPA used the NOAEL from this study to assess
acute dietary exposure. There was also evidence of neurotoxicity
(decreased absolute brain weights) in the 2-generation rat reproduction
study; however, there was no indication of increased susceptibility of
offspring with regard to these effects. Finally, there was no evidence
of neurotoxicity at any dose in the submitted DNT study. Based on the
results of these studies, EPA concluded that there is no need for
additional UFs to account for neurotoxicity.
iii. No qualitative or quantitative increased susceptibility of rat
or rabbit fetuses to in utero exposure in the developmental toxicity
studies was observed. There was no qualitative or quantitative
increased susceptibility in the two generation reproduction study
(rat). There is low concern for increased susceptibility observed in
the DNT study for the reasons noted in Unit III.D.2.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and maximum or average field trial residue values. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fenamidone in drinking water. These
assessments will not underestimate the exposure and risks posed by
fenamidone.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fenamidone will occupy 4.9% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenamidone from food and water will utilize 56% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenamidone.
3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Short- and intermediate-term adverse effects were identified;
however, fenamidone is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- and intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for fenamidone.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenamidone is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fenamidone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatographic method
coupled with tandem mass spectrum detection (LC/MS/MS), Method RPA
407213) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are Codex MRLs for flowerhead brassicas including broccoli,
Chinese broccoli, and cauliflower at 4 ppm; cabbage at 0.9 ppm; lettuce
at 20 ppm; and celery at 40 ppm which are all lower than the proposed
U.S. tolerances. The U.S. tolerances cannot be harmonized (lowered)
because following the label use directions could result in residues
above the Codex MRLs.
C. Revisions to Petitioned-For Tolerances
The petitioner sought separate tolerances on the subgroups 4-16A at
60 ppm and 4-15B at 55 ppm. The Agency is establishing the whole group
tolerance at 60 ppm for group 4-16, in order to harmonize with Canada.
V. Conclusion
Therefore, tolerances are established for residues of fenamidone in
or on basil, dried leaves at 200 ppm; basil, fresh leaves at 30 ppm;
celtuce at 60 ppm; cottonseed subgroup 20C at 0.02 ppm; fennel,
Florence, fresh leaves and stalk at 60 ppm; kohlrabi at 5.0 ppm; leaf
petiole vegetable subgroup 22B at 60 ppm; leafy vegetable group 4-16 at
60 ppm; and the vegetable, Brassica, head and stem, group 5-16 at 5.0
ppm.
Additionally, the following existing crop group tolerances are
being removed since the commodities covered by those crop groups are
covered by the newly established crop group tolerances: Brassica, head
and stem subgroup 5A; Brassica leafy greens, subgroup 5B; cotton,
undelinted seed; and vegetable,
[[Page 35114]]
leafy, except Brassica, group 4. The majority of the commodities in
subgroups 5A and 5B and group 4 are explicitly included in the new
group tolerances, but some commodity entries from the existing subgroup
and group tolerances are not repeated in the new group tolerances. To
clarify how those commodities remain covered, EPA provides the
following explanation. First, subgroup 5A includes two commodities that
are not explicitly covered by other group tolerances: ``cabbage,
Chinese mustard'' and ``cavalo broccolo''. As EPA discussed in its
preamble to the proposed rule amending crop groups, 79 FR 68153 (Nov.
14, 2014), ``cabbage, Chinese mustard'' is not a distinct crop, just a
general reference to leafy, non-heading Brassica greens, which are
covered in group 4-16, and ``cavalo broccolo'' is the same species as
cauliflower, which is covered in group 5-16. Second, subgroup 5B
includes ``mustard spinach''. In the same preamble document, EPA noted
that ``mustard spinach'' is one of several names for mustard greens,
which are covered by the new group 5-16. Third, group 4 includes
``tampala amaranth'', ``chrysanthemum, edible-leaved'', and ``Indian
spinach''. Each of these commodity entries are alternative names for
other commodities still contained in the new group 4-16 and so no
longer necessary: ``edible-leaved chrysanthemum'' is another name for
``chrysanthemum garland''; the preferred name for ``tampala amaranth''
is ``Chinese amaranth''; and the preferred name for ``Indian spinach''
is ``Malabar spinach''. Therefore, residues on commodities listed in
the existing group tolerances are still covered by the establishment of
the new group tolerances.
Lastly, the existing entry for cilantro, leaves is being modified
to read ``Cilantro, fresh leaves'' in accordance with Agency
nomenclature.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 12, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.579;
0
i. Add alphabetically the entries ``Basil, dried leaves''; ``Basil,
fresh leaves''; ``Celtuce''; ``Cottonseed subgroup 20C''; ``Fennel,
Florence, fresh leaves and stalk''; ``Kohlrabi''; ``Leaf petiole
vegetable subgroup 22B''; Leafy vegetable group 4-16''; and Vegetable,
Brassica, head and stem, group 5-16'' to the table in paragraph (a)(1):
0
ii. Remove the entries for ``Brassica, head and stem subgroup 5A'';
``Brassica leafy greens, subgroup 5B''; ``Cotton, undelinted seed'';
and ``Vegetable, leafy, except Brassica, group 4'' from the table in
paragraph (a)(1).
0
iii. Remove the entry ``Cilantro, leaves'' and add in its place
``Cilantro, fresh leaves''.
The additions and revisions read as follows:
Sec. 180.579 Fenamidone; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Basil, dried leaves......................................... 200
Basil, fresh leaves......................................... 30
* * * * *
Celtuce..................................................... 60
Cilantro, fresh leaves...................................... 60
* * * * *
Cottonseed subgroup 20C..................................... 0.02
Fennel, Florence, fresh leaves and stalk.................... 60
* * * * *
Kohlrabi.................................................... 5.0
Leaf petiole vegetable subgroup 22B......................... 60
Leafy vegetable group 4-16.................................. 60
[[Page 35115]]
* * * * *
Vegetable, Brassica, head and stem, group 5-16.............. 5.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-15743 Filed 7-27-17; 8:45 am]
BILLING CODE 6560-50-P